The paranasal sinuses are hollow cavities in the skull connected by small openings, known as ostia, to the nasal canal. Normally, air passes into and out of the paranasal sinuses through the ostia. Also, mucus is continually formed by the mucosal lining of the sinus and drains through the ostia and into the nasal canal.
Sinusitis is a general term that refers to inflammation in one or more of the paranasal sinuses. Acute sinusitis can be associated with upper respiratory infections or allergic conditions which cause tissue swelling and temporarily impedes normal trans-ostial drainage and ventilation of the sinuses, thereby resulting in some collection of mucous and possibly infection within the sinus cavities. Chronic sinusitis is a long term condition characterized by persistent or long term narrowing or blockage of the sinus ostia, resulting in chronic infection and inflammation of the sinuses. Chronic sinusitis is often associated with long standing respiratory allergies, nasal polyps, hypertrophic nasal turbinates and/or deviated internasal septum. While acute sinusitis is typically caused by infection with a single pathogen (e.g., one type of bacteria, one type of virus, one type of fungus, etc.), chronic sinusitis is often associated with multiple pathogen infections (e.g., more than one type of bacteria or more than genus of microorganism).
Chronic sinusitis, if left untreated, can result in irreparable damage to the tissues and/or bony structures of the paranasal anatomy. The initial treatment of chronic sinusitis usually involves the use of drugs such as decongestants, steroid nasal sprays and antibiotics (if the infection is bacterial). In cases where drug treatment alone fails to provide permanent relief, surgical intervention may be indicated.
Functional endoscopic sinus surgery (FESS) is commonly performed use an endoscope and various rigid instruments inserted through the patient's nostril. The endoscope is used to visualize the positioning and use of the operative instruments to perform tasks intended to improve sinus drainage, such as removal of polyps, straightening of deviated septum and excision of mucous membrane and bone to enlarge the narrow the sinus ostia or to create new openings into the sinuses.
Recently the technique known as the Balloon Sinuplasty™ procedure has been developed by Acclarent, Inc. of Menlo Park, Calif. for treatment of sinusitis. A number of copending United States Patent Applications, including patent application Ser. No. 11/789,704, issued as U.S. Pat. No. 8,747,389 on Jun. 10, 2014, Ser. No. 11/355,512, issued as U.S. Pat. No. 8,894,614 on Nov. 25, 2014, Ser. No. 11/150,847, issued as U.S. Pat. No. 7,803,150 on Sep. 28, 2010, Ser. No. 10/944,270, published as U.S. Publication No. 2006/0004323 on Jan. 5, 2006, and Ser. No. 10/829,917, issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010, describe various embodiments of the Balloon Sinuplasty™ procedure as well as various devices useable in the performance of such procedure. In the Balloon Sinuplasty™ procedure, a guide catheter is inserted into the nose and positioned within or adjacent to the ostium of the affected paranasal sinus. A guidewire is then advanced through the guide catheter and into affected paranasal sinus. Thereafter, a dilation catheter having an expandable dilator (e.g., an inflatable balloon) is advanced over the guidewire to a position where the dilator is positioned within the ostium of the affected paranasal sinus. The dilator is then expanded causing dilation of the ostium and remodeling of bone adjacent to the ostium, without required incision of the mucosa or removal of any bone. The catheters and guidewire are then removed and the dilated ostium allows for improved drainage from and ventilation of the affected paranasal sinus.
patent application Ser. No. 11/789,704, issued as U.S. Pat. No. 8,747,389 on Jun. 10, 2014, Ser. No. 11/355,512, issued as U.S. Pat. No. 8,894,614 on Nov. 25, 2014, Ser. No. 11/150,847, issued as U.S. Pat. No. 7,803,150 on Sep. 28, 2010, Ser. No. 10/944,270, published as U.S. Publication No. 2006/0004323 on Jan. 5, 2006, and Ser. No. 10/829,917, issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010, also describe methods for transnasal dilation of other passageways in the ear, nose and/or throat, such as the Eustachian tube and nasolacrimal duct.
In one embodiment, there is provided a dilation catheter device and system that is useable for dilating the ostium of a paranasal sinus, or other passageway within the ear, nose or throat. This dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator, thereby minimizing the number of personnel required for the procedure. Additionally, the dilation catheter device and system of the present invention is useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, an optional handle may be attached to the dilation catheter or to a guide catheter through which the dilation catheter is inserted and such handle may be graspable along with another device (e.g., an endoscope) by a single hand. In this manner, the operator may control the dilation catheter and another device (e.g., an endoscope) with one hand while being free to use his other hand for other purposes.
Further in one embodiment, there are provided systems for treating a disease or disorder of the ear, nose or throat of a human or animal subject. Such systems generally comprise a guide catheter and a working catheter. The working catheter is advanceable through the guide catheter. The guide catheter has a substantially rigid shaft and the working catheter has a proximal portion that is substantially rigid. The working catheter also has a distal portion that is more flexible than the substantially rigid proximal portion. The working catheter is sized relative to the guide catheter so that, at least when the distal portion of the working catheter is advanced out of a distal opening of the guide catheter and the working element is being used to perform a desired diagnostic or therapeutic task, only the substantially rigid proximal portion (or some portion thereof) will extend out of the proximal opening of the guide catheter. In some embodiments, the working catheter may additionally be sized relative to the guide catheter so that the working catheter is initially advanceable to a first position where its distal end of the working catheter has not yet emerged out of the distal end of the guide catheter but only the substantially rigid proximal portion of the working catheter is protruding out of the proximal end of the guide catheter.
Still further in accordance with another embodiment, there are provided sinus ostium dilation catheter devices that generally comprise an elongate catheter shaft having proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section. In some embodiments, the proximal shaft section may extend along at least about 50% of the overall length of the device. A guidewire lumen extends through at least a portion of the catheter shaft to facilitate advancement of the catheter over a guidewire. A dilator is located on the distal shaft section, such dilator having a non-expanded configuration and an expanded configuration.
Still further in accordance with one embodiment, there are provided methods for dilating the ostia of paranasal sinsus and other passageways within the ear, nose or throat of a human or animal subject. In general, such methods comprise the steps of a) inserting a guide catheter having a proximal end and a distal end through one of the subject's nostrils and positioning the guide catheter within or near the passageway to be dilated, b) inserting, through the guide catheter, a dilation catheter comprising i) an elongate catheter shaft having a proximal end, a distal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, ii) a guidewire lumen extending through at least a portion of the catheter shaft to facilitate advancement of the catheter over a that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, ii) a guidewire lumen extending through at least a portion of the catheter shaft to facilitate advancement of the catheter over a guidewire and iii) a dilator located on the distal shaft section, said dilator being in a non-expanded configuration, c) positioning the dilator within the passageway and d) causing the dilator to expand to an expanded configuration, thereby dilating the passageway.
In still a further embodiment, a balloon dilation catheter device is provided that is useable for dilating an opening in a paranasal sinus. The dilation catheter device includes a catheter shaft having a longitudinal axis, an inflation lumen, a distal end, a proximal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section. Also, the catheter shaft is dark in color. An inflatable balloon is disposed on the distal shaft section. The inflatable balloon is connected to the inflation lumen and the inflatable balloon has a non-circular cross-sectional shape when partially inflated. In this embodiment, the balloon dilation catheter includes a first proximal shaft marker disposed on the proximal shaft section, and the first shaft marker having a significantly lighter color than the catheter shaft. The first proximal shaft marker allows a user to approximate, using direct visualization of the first proximal shaft marker, a position of the balloon relative to a guide catheter through which the balloon catheter is advanced. There is also a first distal shaft marker disposed on the distal shaft section proximal to a proximal end of the balloon and the first distal shaft marker has a significantly lighter color than the catheter shaft. The first distal shaft marker enables a user to approximate, using endoscopic visualization of the first distal shaft marker, a position of the balloon relative to an opening of a paranasal sinus.
In one embodiment, a second proximal shaft marker is disposed on the proximal shaft section distally from the first proximal shaft marker and having a significantly lighter color than the catheter shaft. The first proximal shaft marker has a greater length than the second proximal shaft marker. Further, the length of the first proximal shaft marker is equal to the length from a proximal end of the inflatable balloon to the distal end of the catheter shaft. The first proximal shaft marker is spaced from the distal end of the catheter shaft such that it allows the user to approximate when the distal end of the catheter shaft is located at a distal end of the guide catheter and when the proximal end of the balloon exits a guide catheter, and wherein the second proximal shaft marker allows the user to approximate when the distal end of the catheter shaft is located just proximal to a curve in the guide catheter
The balloon dilation catheter device may also include a second distal shaft marker disposed on the distal shaft section proximal to the first distal shaft marker and having a significantly lighter color than the catheter shaft. The first distal shaft marker is disposed at a known distance proximally from the proximal end of the balloon, and the second distal shaft marker is disposed at a known distance proximally from the first distal shaft marker. Also, the first and second distal shaft markers have different appearances. In one embodiment, the first distal shaft marker is disposed approximately one centimeter from the proximal end of the balloon and the second distal shaft marker is disposed approximately two centimeters from the proximal end of the balloon. A third distal shaft marker also may be disposed on the distal shaft section at the proximal end of the balloon.
The balloon dilation catheter device may also include a first radiopaque marker disposed on the distal shaft section and within the inflatable balloon. There may be a second radiopaque marker disposed on the distal shaft section distally from the first radiopaque marker within the balloon. The first and second radiopaque markers are disposed a distance apart from one another to indicate the effective length of the inflatable dilator.
Also, in one embodiment, the inflatable balloon of the balloon dilator catheter device has an approximately triangular cross-section in a partially inflated state. The balloon may also have a balloon neck extending from the balloon proximally along the catheter shaft. The balloon neck allows an endoscopic marker to be disposed on the distal shaft section and underneath the balloon neck.
In an embodiment of a system for treating a disease or disorder of the ear, nose or throat of a human or animal subject, the system includes a guide catheter that is insertable into a head of the subject and has a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening. The system also includes a balloon catheter device as described above that is advanceable out of the distal opening of the guide catheter. The balloon catheter device also includes a guidewire lumen and the system includes a guidewire that is advanceable through the guidewire lumen. Also, the inflation lumen of the catheter shaft is sized so that, after the inflatable balloon has been inflated to a working diameter, the inflatable balloon will deflate in less than 5 seconds with application of negative pressure to the inflation lumen by a conventional balloon catheter inflation and deflation device.
The system may also include an irrigation catheter sized for advancement through the guide catheter into a paranasal sinus.
Furthermore, in an embodiment of a method for dilating a natural paranasal sinus ostium of a paranasal sinus of a patient, the method includes advancing a guide catheter into a head of a patient such that a distal end of the guide catheter is positioned within or near a natural paranasal sinus ostium of a paranasal sinus. Also, the method includes inserting an endoscope into the patient's head and advancing a balloon catheter through a lumen of the guide catheter such that a balloon of the catheter passes out of the distal end of the guide catheter. With the endoscope, a first distal shaft marker disposed on a shaft of the balloon catheter a first known distance from the balloon may be viewed, and also, a second distal shaft marker disposed on the shaft a second known distance from the balloon may be viewed. The method may include approximating a location of the balloon relative to the paranasal sinus ostium, using the first and second distal shaft marker and their known distances from the balloon. The balloon of the balloon catheter may be expanded to remodel or break bone underlying mucusa of the natural paranasal sinus ostium and dilate the ostium.
The method may also include viewing a first proximal shaft marker during the step of advancing the balloon catheter. When a distal end of the first proximal shaft marker enters a proximal end of the guide catheter a distal end of the balloon catheter shaft is located approximately at the distal end of the guide catheter. Also, when a proximal end of the distal shaft marker enters the proximal end of the guide catheter a proximal end of the balloon of the catheter is located approximately at the distal end of the guide catheter.
Further, the method includes viewing a second proximal shaft marker during the step of advancing the balloon catheter. The second proximal shaft marker is disposed distal to the first proximal shaft marker, and when the second proximal shaft marker is located approximately at the proximal end of the guide catheter, the distal end of the balloon catheter is located immediately proximal to a curve in the distal end of the guide catheter. The first distal shaft marker is located proximal to the balloon and the second distal shaft marker is located distal to the balloon.
In another embodiment, the first and second distal shaft markers are located proximal to the balloon. The first distal shaft marker, may be located approximately one centimeter proximal to a proximal end of the balloon and the second distal shaft marker may be located approximately two centimeters proximal to the proximal end of the balloon. The method may also include viewing a third distal shaft marker located at the proximal end of the balloon.
The method may further include advancing a guidewire through the guide and through the ostium before advancing the balloon catheter. After the guidewire is in place, the balloon catheter is advanced over the guidewire and through the guide.
Also, the method may include removing the balloon catheter through the guide catheter and advancing an irrigation catheter through the guide catheter into the paranasal sinus. Once the irrigation catheter is in position, the sinus may be irrigated using the irrigation catheter.
Still further embodiments, aspects, features and details of the present invention will be understood upon reading of the detailed description and examples set forth here below.